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There are a variety of factors pushing the innovation in formulation of drug products forward. The desire to create new delivery methods for biologics, the need to increase patient adherence, and technologies such as artificial intelligence (AI) are some of the trends drug developers in the industry are cultivating.
“The outsourcing partner should offer a broad range of formulation and manufacturing services that support a biopharmaceutical product throughout its entire lifecycle from the initial pre-formulation through to clinical trials and product launch. There should also be seamless technology transfer between the R&D scale research and manufacturing including buffer preparation and formulation protocols, TFF [Tangential Flow Filtration] methods, etc. Having access to a full suite of services enables clients to utilize a single organization for all their formulation and manufacturing requirements, which streamlines and de-risks the process and allows any experience and learnings to be shared across teams. This first-hand knowledge of the product can then be applied to rapidly solve any complex problems which may arise downstream.”
In terms of keeping the patient in mind, Gary recommends early discussions regarding the target product profile and the end user to ensure appropriate strategies are used.
“Obvious strategies include avoiding the use of sugar-type excipients if the end-user group are those prone to conditions such as diabetes,” says Watts, “and avoiding the use of sodium chloride for those with on low-salt diets for hypernatremia or hypertension, for example.”
Read the full article on Pharm Tech.